PMID- 29633389
OWN - NLM
STAT- MEDLINE
DCOM- 20190304
LR  - 20220110
IS  - 1527-3350 (Electronic)
IS  - 0270-9139 (Linking)
VI  - 68
IP  - 4
DP  - 2018 Oct
TI  - 12 Weeks of a Ribavirin-Free Sofosbuvir and Nonstructural Protein 5A Inhibitor 
      Regimen Is Enough to Treat Recurrence of Hepatitis C After Liver Transplantation.
PG  - 1277-1287
LID - 10.1002/hep.29918 [doi]
AB  - Sofosbuvir (SOF) combined with nonstructural protein 5A (NS5A) inhibitors has 
      demonstrated its efficacy in treating a recurrence of hepatitis C virus (HCV) 
      after liver transplantation (LT). However, the duration of treatment and need for 
      ribavirin (RBV) remain unclear in this population. Our aim was to determine 
      whether LT recipients could be treated with an SOF + NS5A inhibitor-based regimen 
      without RBV for 12 weeks post-LT. Between October 2013 and December 2015, 699 LT 
      recipients experiencing an HCV recurrence were enrolled in the multicenter ANRS 
      CO23 CUPILT cohort. We selected patients receiving SOF and NS5A inhibitor +/- RBV 
      and followed for at least 12 weeks after treatment discontinuation. The primary 
      efficacy endpoint was a sustained virological response 12 weeks after the end of 
      treatment (SVR12). Among these 699 patients, 512 fulfilled the inclusion 
      criteria. Their main characteristics were: 70.1% genotype 1, 18.2% genotype 3, 
      21.1% cirrhosis, and 34.4% previously treated patients. We identified four groups 
      of patients according to their treatment and duration: SOF + NS5A without RBV for 
      12 (156 patients) or 24 (239 patients) weeks; SOF + NS5A + RBV for 12 (47 
      patients) or 24 (70 patients) weeks. SVR12 values reached 94.9%, 97.9%, 95.7%, 
      and 92.9%, respectively (P = 0.14). Only 20 patients experienced a treatment 
      failure. Under multivariate analysis, factors such as fibrosis stage, previous 
      treatment, HCV genotype, and baseline HCV viral load did not influence SVR12 
      rates in the four groups (P = 0.21). Hematological adverse events (AEs) were more 
      common in the RBV group: anemia (P < 0.0001) and blood transfusion (P = 0.0001). 
      CONCLUSION: SOF + NS5A inhibitors without RBV for 12 weeks constituted reliable 
      therapy for recurrent HCV post-LT with an excellent SVR12 whatever the fibrosis 
      stage, HCV genotype, and previous HCV treatment. (Hepatology 2018; 00:000-000).
CI  - (c) 2018 by the American Association for the Study of Liver Diseases.
FAU - Houssel-Debry, Pauline
AU  - Houssel-Debry P
AD  - Hepatology and Liver Transplant Unit, Pontchaillou University Hospital, Rennes, 
      France.
FAU - Coilly, Audrey
AU  - Coilly A
AD  - Hepatobiliary Center, AP-HP Paul Brousse Hospital, Villejuif, France.
AD  - Paris Sud University, Paris Sud Saclay University, UMR-S 1193, Villejuif, France.
AD  - INSERM, Unite 1193, Villejuif, France.
AD  - DHU Hepatinov, Villejuif, France.
FAU - Fougerou-Leurent, Claire
AU  - Fougerou-Leurent C
AD  - Pharmacology Unit, CHU Rennes, Rennes, France.
AD  - INSERM, CIC 1414 Clinical Investigation Centre, Rennes, France.
FAU - Jezequel, Caroline
AU  - Jezequel C
AD  - Hepatology and Liver Transplant Unit, Pontchaillou University Hospital, Rennes, 
      France.
FAU - Duvoux, Christophe
AU  - Duvoux C
AD  - Hepatology Unit, Henri Mondor Hospital, AP-HP, Creteil, France.
FAU - De Ledinghen, Victor
AU  - De Ledinghen V
AD  - Hepatogastroenterology Unit, Haut Leveque Hospital, Bordeaux, France.
FAU - Radenne, Sylvie
AU  - Radenne S
AD  - Hepatology Unit, HCL, Hopital de la Croix-Rousse, Lyon, France.
FAU - Kamar, Nassim
AU  - Kamar N
AD  - Nephrology and Organ Transplantation Unit, CHU Rangueil, INSERM U1043, IFR-BMT, 
      Paul Sabatier University, Toulouse, France.
FAU - Leroy, Vincent
AU  - Leroy V
AD  - Hepato-Gastroenterolgy Unit, Pole Digidune, CHU Grenoble, Grenoble, France.
FAU - Martino, Vincent Di
AU  - Martino VD
AD  - Hepatology Unit, CHRU Jean Minjoz Franche Comte University, Besancon, France.
FAU - D'Alteroche, Louis
AU  - D'Alteroche L
AD  - Hepatogastroenterology Unit, CHU Tours, Tours, France.
FAU - Canva, Valerie
AU  - Canva V
AD  - CHRU Lille, Hepatology Unit, Claude Huriez Hospital, CHRU Lille, Lille, France.
FAU - Conti, Filomena
AU  - Conti F
AD  - Hepatology and Liver Transplant Unit, AP-HP, Groupe Hospitalier 
      Pitie-Salpetriere, Paris, France.
FAU - Dumortier, Jerome
AU  - Dumortier J
AD  - Liver Transplant Unit, Digestive Diseases Federation, Edouard Herriot Hospital, 
      Hospices Civils de Lyon Universite Claude Bernard Lyon 1, Lyon, France.
FAU - Montialoux, Helene
AU  - Montialoux H
AD  - Hepatology Unit, CHU Rouen, Charles Nicolle Hospital, Rouen, France.
FAU - Lebray, Pascal
AU  - Lebray P
AD  - Hepatology and Liver Transplant Unit, AP-HP, Groupe Hospitalier 
      Pitie-Salpetriere, Paris, France.
FAU - Botta-Fridlund, Danielle
AU  - Botta-Fridlund D
AD  - Hepatogastroenterology Unit, CHU Timone, Marseille, France.
FAU - Tran, Albert
AU  - Tran A
AD  - Hepatogastroenterology Unit, Nice University Hospital, INSERM, U1065, Equipe 8, 
      Nice Sophia Antipolis University, Faculty of Medicine, Nice, Cedex 2, Nice, 
      France.
FAU - Moreno, Christophe
AU  - Moreno C
AD  - Hepatogastroenterology Unit, CUB Hopital Erasme, Brussels University, Bruxelles, 
      Belgique.
FAU - Silvain, Christine
AU  - Silvain C
AD  - Hepatogastroenterology Unit, CHU Poitiers, Poitiers, France.
FAU - Besch, Camille
AU  - Besch C
AD  - Liver Transplant and Digestive Surgery Unit, Strasbourg University, Strasbourg, 
      France.
FAU - Perre, Philippe
AU  - Perre P
AD  - Infectious Diseases Unit, CHD Vendee, La Roche sur Yon, Strasbourg, France.
FAU - Francoz, Claire
AU  - Francoz C
AD  - Hepatology Unit, Beaujon Hospita, Assistance Publique-Hopitaux de Paris, Clichy, 
      France.
FAU - Abergel, Armando
AU  - Abergel A
AD  - Hepatogastroenterology Unit, CHU Estaing Clermont-Ferrand, Clermont-Ferrand, 
      France.
FAU - Habersetzer, Francois
AU  - Habersetzer F
AD  - Universitary Hospitals of Strasbourg, Inserm U 1110, LabEx HepSYS, Strasbourg 
      University, Strasbourg, France.
FAU - Debette-Gratien, Maryline
AU  - Debette-Gratien M
AD  - Hepatogastroenterology Unit, CHU Limoges, Limoges, France.
FAU - Cagnot, Carole
AU  - Cagnot C
AD  - Unite de recherche Clinique et Fondamentale sur les Hepatites Virales, ANRS 
      (France REcherche Nord&sud Sida-hiv Hepatites), Paris, France.
FAU - Diallo, Alpha
AU  - Diallo A
AD  - Unite de recherche Clinique et Fondamentale sur les Hepatites Virales, ANRS 
      (France REcherche Nord&sud Sida-hiv Hepatites), Paris, France.
FAU - Chevaliez, Stephane
AU  - Chevaliez S
AD  - Virology Unit, French National Reference Center for Viral Hepatitis B, C and 
      delta French National Reference Center for Viral Hepatitis B, C and delta, 
      Hopital Henri Mondor, Universite Paris 12, Paris, France.
FAU - Rossignol, Emilie
AU  - Rossignol E
AD  - Pharmacology Unit, CHU Rennes, Rennes, France.
AD  - INSERM, CIC 1414 Clinical Investigation Centre, Rennes, France.
FAU - Veislinger, Aurelie
AU  - Veislinger A
AD  - Pharmacology Unit, CHU Rennes, Rennes, France.
AD  - INSERM, CIC 1414 Clinical Investigation Centre, Rennes, France.
FAU - Duclos-Vallee, Jean-Charles
AU  - Duclos-Vallee JC
AD  - Hepatobiliary Center, AP-HP Paul Brousse Hospital, Villejuif, France.
AD  - Paris Sud University, Paris Sud Saclay University, UMR-S 1193, Villejuif, France.
AD  - INSERM, Unite 1193, Villejuif, France.
AD  - DHU Hepatinov, Villejuif, France.
FAU - Pageaux, Georges-Philippe
AU  - Pageaux GP
AD  - Liver transplant and Hepatogastroenterology Unit, CHU Saint-Eloi, Montpellier 
      University, Montpellier, France.
CN  - the ANRS CO23 CUPILT study group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hepatology
JT  - Hepatology (Baltimore, Md.)
JID - 8302946
RN  - 0 (Viral Nonstructural Proteins)
RN  - 49717AWG6K (Ribavirin)
RN  - EC 2.7.7.48 (NS-5 protein, hepatitis C virus)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Belgium
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - France
MH  - Graft Survival/drug effects
MH  - Hepatitis C, Chronic/complications/diagnosis/drug therapy
MH  - Humans
MH  - Liver Cirrhosis/etiology/*surgery/virology
MH  - Liver Transplantation/*adverse effects/methods
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Prospective Studies
MH  - Recurrence
MH  - Ribavirin/therapeutic use
MH  - Sofosbuvir/*therapeutic use
MH  - Treatment Outcome
MH  - Viral Nonstructural Proteins/*administration & dosage/*antagonists & inhibitors
EDAT- 2018/04/11 06:00
MHDA- 2019/03/05 06:00
CRDT- 2018/04/11 06:00
PHST- 2017/10/16 00:00 [received]
PHST- 2018/04/02 00:00 [accepted]
PHST- 2018/04/11 06:00 [pubmed]
PHST- 2019/03/05 06:00 [medline]
PHST- 2018/04/11 06:00 [entrez]
AID - 10.1002/hep.29918 [doi]
PST - ppublish
SO  - Hepatology. 2018 Oct;68(4):1277-1287. doi: 10.1002/hep.29918.